Apparatus and method to reshape geometry of diseased heart valve

ABSTRACT

Devices and methods are disclosed for treating mitral valve regurgitation that include members that assist the valve in closing during the cardiac cycle. Such devices may include members configured to alter the shape of mitral valve annulus. In certain embodiments, one or more wires may be anchored on one extremity to an element positioned along the posterior part of the mitral annulus, in the coronary sinus, and on another extremity to an element along the anterior part of the mitral annulus, fibrous trigon. The reshaping of the mitral annulus may be accomplished by pulling the wire or wires. Reducing the length of the wire or wires may provide the displacement of the posterior leaflets towards the anterior, thereby increasing the coaptation surface for the valve leaflets and reducing the regurgitation.

I. CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/109,437 entitled Apparatus and method to reshape geometry of diseasedheart valve,” and filed on 30 Jun. 2016, which is the national stage forInternational Patent Cooperation Treaty Application PCT/US2014/073084,filed Dec, 31, 2014, which claims the benefit of U.S. Provisional PatentApplication No. 61/923,319, entitled “Apparatus and method to reshapegeometry of diseased heart valve,” and filed on 3 Jan. 2014. Theentirety of the foregoing patent applications is incorporated byreference herein.

II. TECHNICAL FIELD

The present disclosure relates to the repair and/or correction ofdysfunctional heart valve. More particularly pertains to mitral valveregurgitation treatment using only endovascular techniques deployingdevices that passively assist to close a heart valve to improve valvefunction.

II. BACKGROUND

A human heart has four chambers, the left and right atrium and the leftand right ventricles. The chambers of the heart alternately expand andcontract to pump blood through the vessels of the body. The cycle of theheart includes the simultaneous contraction of the left and right atria,passing blood from the atria to the left and right ventricles. The leftand right ventricles then simultaneously contract forcing blood from theheart and through the vessels of the body. In addition to the fourchambers, the heart also includes a check valve at the upstream end ofeach chamber to ensure that blood flows in the correct direction throughthe body as the heart chambers expand and contract. These valves maybecome damaged, or otherwise fail to function properly, resulting intheir inability to properly close when the downstream chamber contracts.Failure of the valves to properly close may allow blood to flow backwardthrough the valve resulting in decreased blood flow and lower bloodpressure.

Mitral regurgitation occurs when the mitral valve separating the leftatrium and the left ventricle fails to properly close. As a result, uponcontraction of the left ventricle blood may leak or flow from the leftventricle back into the left atrium, rather than being forced throughthe aorta.

The mitral valve has 2 leaflets, anterior and posterior, both connectedon one side to the mitral annulus and on the free edges to the cordaeand cardiac muscle. In order to close properly, the free edges of thetwo leaflets have to touch each other over a length of severalmillimeters and this is called leaflets coaptation. Mitral regurgitationis mainly due to a lack of leaflets coaptation as a consequence ofannulus dilatation or cardiac muscle dysfunction. Regardless of thecause, mitral regurgitation may result in a decrease in blood flowthrough the body (cardiac output) and deserve surgical treatment.

III. BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B depict cross-sectional views of a normal mitral valve and aregurgitant mitral valve in accordance with certain embodiments.

FIGS. 2A-B depict cross-sectional views of a regurgitant mitral valveand a reshaped mitral valve in accordance with certain embodiments.

FIG. 3 depicts a cross-sectional view of a heart in accordance withcertain embodiments.

FIG. 4 depicts placement of a posterior holding element in accordancewith certain embodiments.

FIG. 5 depicts placement of an anterior holding element in accordancewith certain embodiments.

FIG. 6 depicts placement of one or more wires through the micro-aorticjunction in accordance with certain embodiments.

FIG. 7 depicts pulling the one or more wires through the mitro-aorticjunction to correct mitral regurgitation in accordance with certainembodiments.

FIG. 8 depicts locking the one or more wires over an anterior holdingelement in accordance with certain embodiments.

FIG. 9 depicts the one or more wires installed to increase leafletscoaptation in accordance with certain embodiments,

FIGS. 10A-B depict a method of installing three wires to increaseleaflets coaptation in accordance with certain embodiments.

FIG. 11 depicts a method of installing wires into the trigon region inaccordance with certain embodiments.

FIG. 12 depicts a method of coupling wires in the trigon region inaccordance with certain embodiments.

FIG. 13 depicts an assembled posterior holding element and connectingelement in accordance with certain embodiments.

FIG. 14 depicts a method of connecting the free end of a connectingelement to a wire exiting the femoral vein in accordance with certainembodiments.

FIGS. 15A-B depict a method of pulling a wire that exits the femoralartery until the assembled element reaches the coronary sinus inaccordance with certain embodiments.

FIG. 16 depicts a method of positioning an anterior holding elementbelow the aortic valve at the level of the fibrous trigon in accordancewith certain embodiments.

FIG. 17 depicts a method of adjusting the connecting element length andlocking the anterior holding element to the connecting element inaccordance with certain embodiments.

FIGS. 18A-B depict changing the profile of one or more wires during acardiac cycle in accordance with certain embodiments.

IV. DETAILED DESCRIPTION

Devices and methods are disclosed for treating mitral valveregurgitation that include members that assist the valve in closingduring the cardiac cycle. Such devices may include members configured toalter the shape of mitral valve annulus. In certain embodiments, one ormore wires may be anchored on one extremity to an element positionedalong the posterior part of the mitral annulus, in the coronary sinus,and on another extremity to an element along the anterior part of themitral annulus, fibrous trigon. The reshaping of the mitral annulus maybe accomplished by pulling the wire or wires. Reducing the length of thewire or wires may provide the displacement of the posterior leafletstowards the anterior, thereby increasing the coaptation surface for thevalve leaflets and reducing the regurgitation.

In certain embodiments, an annuloplasty device is disclosed, comprising:a first holding element configured to be located in a coronary sinus ofa heart; a second holding element configured to be located in a fibroustrigon of the heart; and one or more connecting elements for connectingthe first holding element and the second holding element, the one ormore connecting elements configured to pull the first holding elementtoward the second holding element to reduce the distance between ananterior portion of the mitral annulus of the heart and a posterioronion of the mitral annulus, thereby increasing mitral valve leafletscoaptation. The one or more connecting elements may be configured tocross the valve area on the atrial side. The first and second holdingelements and the one or more connecting elements may be configured to bedeployed into the heart using endovascular techniques. At least one ofthe one or more connecting elements may be configured to change itsprofile during a cardiac cycle to prevent mitral leaflets damage due toimpingement of one or more mitral valve leaflets on the at least oneconnecting element during ventricular systole. At least one of the oneor more connecting elements may be configured to change its profileduring a cardiac cycle not to block blood flow from atrium to ventricle.A plurality of the one or more connecting elements may be configured tobe joined in situ to form a single connecting element.

In certain embodiments, the first holding element may be configured tobe located in a coronary sinus of a heart and one connecting element forconnecting the first holding element and the second holding element, maybe assembled with the first holding element into a single element beforethe implant.

In certain embodiments, a method of inserting an annuloplasty device isdisclosed, comprising: placing a first holding element into a coronarysinus of a heart; connecting one or more connecting elements to thefirst holding element; pulling at least one of the one or moreconnecting elements to increase mitral valve leaflet coaptation;connecting the one or more connecting elements to a second holdingelement at the level of the mitro-aortic junction and fibrous trigon ofa heart. The step of connecting one or more connecting elements to thefirst holding element may comprise placing one or more connectingelements through the mitro-aortic junction of a heart. The step ofconnecting the one or more connecting elements to the first holdingelement may comprise: piercing the left ventricle outflow tract at thelevel of fibrous trigon with a first connecting element; extending thefirst connecting element across a valve area towards the posteriormitral annulus of the heart; piercing the mitral annulus and thecoronary sinus with the first connecting element and connecting thefirst connecting element to the first holding element. One of the one ormore connecting elements may be placed in the left ventricle outflowtract at the level of the fibrous trigon, below the aortic valve usingendovascular techniques. At least one of the one or more connectingelements may change its profile during a cardiac cycle to prevent mitralleaflet damage due to impingement of one or more mitral valve leafletson the at least one connecting element during ventricular systole. Atleast one of the one or more connecting elements may change its profileduring a cardiac cycle and may not block blood flow from atrium toventricle. The method may further comprise adjusting the length of theconnecting element. The step of adjusting the length of the connectingelement may be performed during a selected one of an initial procedureto install the annuplasty device and a later procedure after the initialprocedure is completed.

In certain embodiments, a method of inserting an annuloplasty device isdisclosed, comprising: connecting a first holding element to one or moreconnecting elements; placing the first holding element connected to theone or more connecting elements into the coronary sinus of the heart;connecting the one or more connecting elements to a second holdingelement placed at the level of the micro-aortic junction and fibroustrigon of a heart; pulling at least one of the one or more connectingelements to increase mitral valve leaflets coaptation. The step ofconnecting the one or more connecting elements to the second holdingelement may comprise: piercing a coronary sinus of the heart with afirst holding element connected to one or more connecting elementsavoiding the circonflex artery of the heart; extending the firstconnecting element across a valve area towards the fibrous trigon on theatrial side of the valve; piercing the left ventricle outflow tract atthe level of the fibrous trigon with the first connecting element;pulling at least one of the one or more connecting elements to increasemitral valve leaflets coaptation; and connecting the first connectingelement to the second holding element. One of the one or more connectingelements may be placed in the left ventricle outflow tract at the levelof the fibrous trigon, below the aortic valve using endovasculartechniques. At least one of the one or more connecting elements maychange its profile during a cardiac cycle to prevent mitral leafletdamage due to impingement of one or more mitral valve leaflets on the atleast one connecting element during ventricular systole. At least one ofthe one or more connecting elements may change its profile during acardiac cycle and may not block blood flow from atrium to ventricle. Aplurality of the one or more connecting elements may be joined in situto form a single connecting element.

To reduce mitral regurgitation, certain embodiments increase leafletscoaptation by pulling the posterior annulus toward the anterior (FIGS. 1and 2) using 2 holding elements and wires. FIG. 1A depicts a normalmitral valve 110, wherein leaflets coaptation allows the mitral valve totightly seal. FIG. 1B depicts a regurgitant mitral valve 120 that lacksleaflets coaptation due to mitral annulus dilation, preventing the valvefrom achieving a tight seal. In certain embodiments, it is desired toreduce distance A-P as depicted in FIGS. 2A-B to improve leafletcoaptation in the mitral valve. FIG. 2A depicts distance A-P inregurgitant mitral valve 210, which FIG. 2B depicts reshaped mitralvalve 220 with reduced distance A-P.

In certain embodiments, the procedure can be totally endovascular,alleviating the need for open-heart surgery, and may utilize anatomicalrelationships between the mitral annulus, coronary sinus 310, fibroustrigon 320 and aortic valve as shown in FIG. 3.

In certain embodiments, the procedure may consist of 4 steps:

In certain embodiments as shown in FIG. 4. Step 1 may include insertionf posterior holding element into the coronary sinus through the femoralvein. An exemplary holding element 410 is shown and described in FIG. 4.The posterior holding element 410 may be a rod that reproduces thesaddle shape of the posterior part of the mitral annulus. In certainembodiments, the posterior holding element 410 may be made of stainlesssteel, but one of ordinary skill in the art will recognize that othermetals or polymers may be used. In certain embodiments, conventionaltechniques of placement may be used such as techniques known to one ofordinary skill in for positioning pacemaker electrodes and/or a Carillondevice.

In certain embodiments as shown in FIG. 5, Step 2 may include placementof the wires trough the fibrous trigon, which may be accomplished usingexisting transcatheter technology. A delivery catheter 510 may beinserted into femoral artery and advanced into the aorta, below theaortic valve at the level of the mitro-aortic junction (FIG. 5). Thewire may be inserted into the delivery catheter 510. The wire may piercethe fibrous trigon 520 and may be directed toward the posterior holdingelement 530 under fluoroscopy control. In certain embodiments as shownin FIG. 6, the wire may pierce the posterior mitral annulus and maycatch the posterior holding element 530 (FIG. 6). One of ordinary skillin the art will recognize that the posterior holding element may beattached to the wire prior to insertion via the catheter.

In certain embodiments as shown in FIG. 7, Step 3 may include pulling ofthe posterior holding element 530. Once the wire 610 is connected to theposterior holding element 530, the wire 610 may be pulled through thedelivery catheter 510 to reduce the Antero-Posterior distance, therebyincreasing leaflets coaptation and correcting mitral regurgitation.

In certain embodiments as shown in FIG. 8, Step 4 may include lockingwire 610 over anterior holding element 810. An anterior holding element810 may be inserted into the delivery catheter 510. The anterior holdingelement 810 may have a rod shape and may be made of metal or polymer orother suitable materials known to those of skill in the art. Theanterior holding element 810 may be placed at the level of themitro-aortic junction. The wire may be locked over the anterior holdingelement 810. In certain embodiments as shown in FIG. 9, the deliverycatheter 510 may be retrieved and the procedure completed.

The number of wires varies according to the severity of the mitralregurgitation. In FIGS. 10A and B, an embodiment with 3 wires 1010 isillustrated. FIG. 10A depicts a mitral valve exhibiting mitralregurgitation due to the absence of leaflet coaptation. FIG. 10B shows amitral valve with three wires 1010 used to connect anterior holdingelement 1020 and posterior holding element 1030. One of ordinary skillin the art will recognize that the number of wires 1010 may be varieddepending on the severity of the mitral regurgitation. In certainembodiments, steps 2-4 above may be repeated for each subsequent wire1010 until the desired number of wires 1010 has been installed. Once thedesired number of wires 1010 has been installed, the delivery catheter510 may be retrieved and the procedure completed.

In certain embodiments, the procedure may consist of 5 steps:

In certain embodiments as shown in FIG. 11, Step 1 may include placementof the wires through the fibrous trigon, which may be accomplishedwithout limitation using existing transcatheter technology or othermethods known to those of skill in the art. A delivery catheter 1110 maybe inserted into a femoral artery and advanced into the aorta, below theaortic valve at the level of the mitro-aortic junction as shown in FIG.5. The wire 1120 may be inserted into the delivery catheter 1110. Thewire 1120 may pierce the fibrous trigon and be kept floating in the leftatrium

In certain embodiments, Step 2 may include placement of the wires intothe coronary sinus using existing transcatheter technology or othermethods known to those of skill in the art. A delivery catheter 1130 maybe inserted into the femoral vein and advanced into the coronary sinus(great cardiac vein). The wire 1140 may be inserted into the deliverycatheter and advanced. The wire 1140 may pierce the wall of the leftatrium at the level where the connecting element has to be placed. Thewire 1140 may be kept floating in the left atrium.

In certain embodiments as shown in FIG. 12, Step 3 may include joiningthe wire 1120 coining from the fibrous trigon and wire 1140 coming fromthe coronary sinus (shown in FIG. 11), using magnetic coupling force orusing other existing transcatheter technology such as snare wires. Thisaction may result in having one single wire 1210 going from the femoralvein to the femoral artery trough the coronary sinus and fibrous trigon.

In certain embodiments as shown in FIGS. 13-15, Step 4 may includeconnection of the assembled device to the wire 1410 on the vein end. Thefree end 1310 of the connecting element 1320, the one to be connected tothe holding element 1330 to be located in the fibrous trigon, isconnected to the wire 1410 on the vein end as shown in FIGS. 13 and 14.Pulling the wire 1410 through the arterial end as shown in FIG. 15A mayallow the positioning of assembled device into the coronary sinus first.Once the holding element 1330 to be located in the coronary sinus is inplace as shown in FIG. 15B, the wire 1410 is pulled till the connectingelement 1320 is completely deployed over the mitral valve and reachesthe fibrous trigon, below the aortic valve as shown in FIG. 15B.

In certain embodiments as shown in FIG. 16, Step 5 may include lockingthe wire 1410 over anterior holding element 1610. An anterior holdingelement 1610 may be inserted into the delivery catheter. The anteriorholding element 1610 may have a rod shape and may be made of metal orpolymer or other suitable material known to those skilled in the art.The anterior holding element may be placed at the level of themitro-aortic junction.

In certain embodiments as shown in FIG. 17, the locking system may bereleased and connecting element length may be adjusted as many times asnecessary. The adjustment may be done during the implant procedureand/or during a second or subsequent procedure. The second or subsequentprocedure may be done after days, months or years.

In another embodiment, at least one of the wires may change its profileaccording to the direction of blood flow. FIG. 18 presents a left atrialview. During ventricular filling the wire may have a very low profile tofacilitate the blood flow as shown in FIG. 18A. During ventricularcontraction the wire may increase its profile as shown in FIG. 18B,improving mitral regurgitation correction and reducing mechanical stresson mitral valve leaflets.

Certain embodiments may provide advantages over the prior art. Forexample, certain embodiments may allow treatment of mitral valveregurgitation without open-heart surgery. Mitral valve repair orreplacement generally is accomplished by a major open-heart surgicalprocedure, requiring general anesthesia, full cardiopulmonary bypasswith complete cessation of cardiopulmonary activity, seven to ten daysof hospitalization and months of recuperation time. The mortality ratewith this type of procedure is about five to six percent.

One commonly employed repair technique in open-heart surgery involvesthe use of annuloplasty rings. An annuloplasty ring has a diameter thatis less than the diameter of the enlarged valve annulus. The ring isplaced in the valve annulus and the tissue of the annulus sewn orotherwise secured to the ring. This causes a reduction in the annularcircumference and an increase in the leaflet coaptation area.

Endovascular heart procedures, in contrast to open heart surgicalprocedures, would require only local anesthesia, no cardiac bypass, oneto two days hospitalization, and should have a reduced mortality rate ascompared to open heart procedures.

Therefore, effective techniques that could improve valve functionwithout the need for cardiopulmonary bypass may be advantageous. Inparticular, passive techniques to change the shape of the valve reducingregurgitation while maintaining substantially normal leaflet motion maybe desirable. In addition, a technique that can be employed on a beatingheart would allow the practitioner an opportunity to assess the efficacyof the treatment and address any inadequacies without the need foradditional bypass support.

However, as discussed in the literature, there are limited possibilitiesto achieve effective endovascular correction of mitral regurgitation.Existing devices and techniques such as Mitraclip System (Abbott),Cardioband (Valtech Cardio) and Carillon (Cardiac Dimensions) haveprovided limited evidence of clinical benefit, mainly because theyfailed to achieve a significant increase in leaflets coaptation. Certainembodiments of the present invention overcome the disadvantages of theforegoing techniques.

For the first time it is possible to increase leaflets coaptationsimilarly to the technique used in open-heart surgery, using only atranscatheter approach.

Certain embodiments employ the novel method of using wires crossing theorifice of the mitral valve, which was not previously recommended due topotential mitral leaflets damage. The use of wires having the profilechanging over the cardiac cycle should minimize leaflets damage.

While the above description contains many specifics, these should not beconstrued as limitations on the scope of the invention, but rather as anexemplification of preferred embodiments thereof. The invention includesany combination or subcombination of the elements from the differentspecies and/or embodiments disclosed herein. One skilled in the art willrecognize that these features, and thus the scope of the presentinvention, should be interpreted in light of the following claims andany equivalents thereto.

We claim:
 1. A method of inserting an annuloplasty device, comprising:connecting a first holding element to one or more connecting elements;placing the first holding element connected to the one or moreconnecting elements into the coronary sinus of the heart; connecting theone or more connecting elements to a second holding element placed atthe level of the mitro-aortic junction and fibrous trigon of a heart;pulling at least one of the one or more connecting elements to increasemitral valve leaflets coaptation.
 2. The method of claim 1, wherein thestep of connecting the one or more connecting elements to the secondholding element comprises: piercing a coronary sinus of the heart with afirst holding element connected to one or more connecting elementsavoiding the circonflex artery of the heart; extending the firstconnecting element across a valve area towards the fibrous trigon on theatrial side of the valve; piercing the left ventricle outflow tract atthe level of the fibrous trigon with the first connecting element;pulling at least one of the one or more connecting elements to increasemitral valve leaflets coaptation; and connecting the first connectingelement to the second holding element.
 3. The method of claim 1, whereinone of the one or more connecting elements is placed in the leftventricle outflow tract at the level of the fibrous trigon, below theaortic valve using endovascular techniques.
 4. The method of claim 1,wherein at least one of the one or more connecting elements changes itsprofile during a cardiac cycle to prevent mitral leaflet damage due toimpingement of one or more mitral valve leaflets on the at least oneconnecting element during ventricular systole.
 5. The method of claim 1,wherein at least one of the one or more connecting elements changes itsprofile during a cardiac cycle and does not block blood flow from atriumto ventricle.
 6. The method of claim 1, wherein a plurality of the oneor more connecting elements are joined in situ to form a singleconnecting element.